FDA.reportPublic FDA data

MAUDE MDR 9238676

MDR report key
9238676
Report number
8010042-2019-00784
Event key
0
Event type
3
Date of event
2019-09-29
Date received
2019-10-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
MAQUET CRITICAL CARE AB R SOLNA SW
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPRESSOR MINICOMPRESSOR, AIR, PORTABLEMAQUET CRITICAL CARE ABBTICOMPR MINI 230V 50HZ6481787N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-250

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE COMPRESSOR ALARMED FOR LOW AIR PRESSURE. THERE WAS NO PATIENT HARM. (B)(4).